Clinical trial · Interventional
Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer
Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer: A Randomized Clinical Trial
NCT04221165CI-TRIAL-00074412completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the daily pain level scores for patients taking opioids alone for pain relief, compared with those treated by multimodal analgesia with three medications: pregabalin, naproxen, and acetaminophen, with the ability to switch over to opioid medications if needed. In addition to pain level scores, this study will compare opioid use (length of time and doses taken), quality of life, admissions to hospital, feeding tube requirements, weight loss, and treatment interruptions between these two analgesic regimens.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation-Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Opioids | Drug | — | UNRESOLVED |
| PAiN - multimodal analgesia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Opioid Analgesia
- description
- Opioids will be prescribed as per institutional standards. Examples of opioids are morphine and hydromorphone.
- interventionNames
- Drug: Opioids
- type
- EXPERIMENTAL
- label
- Multimodal Analgesia
- description
- Pregabalin (50 mg to 300 mg, oral, twice daily), acetaminophen (1000 mg, oral, 3 times per day), naproxen 250 mg to 500 mg, oral, twice daily), and pantoprazole magnesium (40 mg, oral, daily)
- interventionNames
- Drug: PAiN - multimodal analgesia
Primary outcomes (1)
- measure
- Average Pain Rating measured on the 11 Numeric Rating Scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Willing to provide consent * Histologically confirmed mucosal head and neck malignancy * Undergoing chemoradiotherapy or radiotherapy alone with a planned total radiation dose of 50 Gray (Gy) or greater * Eastern Co-operative Oncology Group (ECOG) performance status 0-2 * Life expectancy \> 6 months * Onset of 4/10 pain on the 11-Numeric Rating Scale that is localized to the mucosa of the mouth or throat, before or during radiation treatment, that is not caused by a current oral candidiasis infection. * Ability to take pills, either by mouth or crushed via NasoGastric (NG) tube or Gastrostomy tube (G-tube) * Ability to complete the study questionnaires and pain diary * Ability to sign consent without requirement for a substitute decision maker Exclusion Criteria: * Skin and salivary gland malignancies * High daily opioid use at time of enrollment (defined as 30 mg oral morphine equivalent dose or higher) * Concurrent second active malignancy * Pregnant or lactating women * Psychological disorder requiring pharmacologic treatment * Regular systemic steroid use * Regular anticonvulsant or antidepressant use * Renal Impairment (defined as creatinine clearance \< 60 mL/min) * Liver Dysfunction (defined as total bilirubin \> 34.2 µmol/L) * Documented true allergy to acetaminophen, NSAIDs, pregabalin or opioids * History of upper gastrointestinal bleed * Known bleeding disorder * History of or current substance use disorder
References
Publications (6)
- BACKGROUNDElad S, Yarom N. The Search for an Effective Therapy and Pain Relief for Oral Mucositis. JAMA. 2019 Apr 16;321(15):1459-1461. doi: 10.1001/jama.2019.3269. No abstract available. PMID 30990535
- BACKGROUNDLalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, McGuire DB, Migliorati C, Nicolatou-Galitis O, Peterson DE, Raber-Durlacher JE, Sonis ST, Elad S; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014 May 15;120(10):1453-61. doi: 10.1002/cncr.28592. Epub 2014 Feb 25. PMID 24615748
- BACKGROUNDMirabile A, Airoldi M, Ripamonti C, Bolner A, Murphy B, Russi E, Numico G, Licitra L, Bossi P. Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations. Crit Rev Oncol Hematol. 2016 Mar;99:100-6. doi: 10.1016/j.critrevonc.2015.11.010. Epub 2015 Dec 3. PMID 26712589
- BACKGROUNDAlfieri S, Ripamonti CI, Marceglia S, Orlandi E, Iacovelli NA, Granata R, Cavallo A, Pozzi P, Boffi R, Bergamini C, Imbimbo M, Pala L, Resteghini C, Mirabile A, Locati LD, Licitra L, Bossi P. Temporal course and predictive factors of analgesic opioid requirement for chemoradiation-induced oral mucositis in oropharyngeal cancer. Head Neck. 2016 Apr;38 Suppl 1:E1521-7. doi: 10.1002/hed.24272. Epub 2016 Feb 5. PMID 26849016
- DERIVEDZayed S, Lang P, Read N, Correa RJM, Mutsaers A, Goodman CD, D'Angelo K, Kieraszewicz K, Vanwynsberghe D, Kingsbury-Paul A, Crewdson K, Neeb J, Carreau C, Winquist E, Kuruvilla S, Stewart P, Moulin DE, Warner A, Palma DA. Opioid therapy vs. Multimodal analgesia in head and neck cancer (OPTIMAL-HN): Results of a randomized clinical trial. Radiother Oncol. 2025 May;206:110831. doi: 10.1016/j.radonc.2025.110831. Epub 2025 Mar 5. PMID 40054624
- DERIVEDZayed S, Lang P, Mendez LC, Read N, Sathya J, Venkatesan V, Moulin DE, Warner A, Palma DA. Opioid therapy vs. multimodal analgesia in head and neck Cancer (OPTIMAL-HN): study protocol for a randomized clinical trial. BMC Palliat Care. 2021 Mar 19;20(1):45. doi: 10.1186/s12904-021-00735-0.